Customized cochlear implant settings for adults with deafness, based on hearing nerve health
Tests customized cochlear implant programs for speech in noise in adults with deafness.
Key facts
- Who runs it
- Massachusetts Eye and Ear Infirmary
- Where
- Boston, United StatesSee the site
- Trial code
- Registry title
- Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology
- Status
- Recruiting
- People taking part
- 45 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 30 Jul 2028
- Type of study
- Interventional
- Treatments tested
- Everyday Clinical Listening Program (Control)
- ENI-Based Experimental Program 1
- ENI-Based Experimental Program 2
- Record updated
- 9 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with hearing loss in both ears who use an Advanced Bionics cochlear implant. It tests new ways of programming the implant to help people understand speech in noise.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Hearing loss in both ears. People must wear a cochlear implant made by Advanced Bionics (Clarion Hi-Focus I or newer).
- Earlier treatment
- At least 6 months of listening experience with the cochlear implant. People can be recruited and give consent before that.
Main reasons for not taking part
- Lost hearing before age 3-4 years (when language is learned) but got a cochlear implant only as an adult
- No age-appropriate speech testing from clinic visits, or not using the implant for spoken communication
- Neurological disease
- Facial nerve stimulation or pain from the implant that cannot be managed, or not tolerating the implant well
- Not able to give informed consent, do the study tasks, or see well enough to do tasks on a computer screen
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Age 18 - 80 years old
- Native speakers of American English or Multilingual
- Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer)
- At least 6 months of listening experience with their cochlear implant, but could be recruited and consented prior
- Bilateral hearing loss
Who cannot take part
- Lost their hearing prior to the age of language acquisition (3-4 years) but did not receive a cochlear implant until adulthood
- Have unmanageable facial nerve stimulation or pain as a result of their implant
- Does not tolerate implant well
- Have neurological disease
- Do not have age-appropriate speech perception testing from clinical visits or do not use their implant for oral communication
- Inability to provide informed consent
- Unable to carry out the study protocol or tasks required in the study
- Poor vision such that the subject cannot adequately perform the study tasks on the computer screen
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- Massachusetts Eye and EarBoston, United StatesContact: Julie Arenberg, PhD, CCC-ATaking people
About the trial
What the trial wants to find out
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.
Read full original descriptionShow less
This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.
The group in the trial
- All Participants (Within-Subjects Crossover)Treatment being tested
This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates. In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized.
Treatment: Everyday Clinical Listening Program (Control), ENI-Based Experimental Program 1, and ENI-Based Experimental Program 2
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology
- Plain-language title
- Customized cochlear implant settings for adults with deafness, based on hearing nerve healthGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07683689, who can take part
- Record updated
- 9 October 2026